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Computer-Assisted Method for Adaptive, Risk-Based Monitoring of Clinical Studies

机译:基于计算机辅助方法的适应性,基于风险的临床研究监测

摘要

A computer-assisted method is described for continuously assessing the quality of field data in a clinical study, identifying areas of weakness and specific sites where performance may be less than desirable, and flexibly allocating resources to address the problems, including the need to travel to the site to either check data or address problem areas. This method involves specification of key performance indicators that include elements that, preferentially, can be measured from a central location and do not require physical presence at the site to be checked. Such indicators can be continuously evaluated for correlation with desired performance levels, and modified accordingly. This approach thus is both risk-based and adaptive, and specifically enables clinical trial managers to address quality issues without the need to travel to the sites.
机译:描述了一种计算机辅助方法,用于连续评估临床研究中的现场数据质量,识别性能可能不理想的弱点区域和特定部位,并灵活分配资源以解决问题,包括需要前往该站点可以检查数据或解决问题区域。此方法涉及关键性能指标的规范,这些指标包括可以从中心位置进行测量的元素,并且不需要在要检查的站点上实际存在。可以连续评估此类指标与所需性能水平的相关性,并进行相应的修改。因此,这种方法既基于风险又具有适应性,并且特别使临床试验管理人员无需前往现场即可解决质量问题。

著录项

  • 公开/公告号US2014324553A1

    专利类型

  • 公开/公告日2014-10-30

    原文格式PDF

  • 申请/专利权人 MICHAEL JOSEPH ROSENBERG;

    申请/专利号US201313956680

  • 发明设计人 MICHAEL JOSEPH ROSENBERG;

    申请日2013-08-01

  • 分类号G06Q10/06;G06F19/00;

  • 国家 US

  • 入库时间 2022-08-21 16:08:03

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